Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
4 participants
INTERVENTIONAL
2018-08-01
2020-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CD19-CART with a murine scFv
All enrolled patients in this arm will receive CD19-CART with a murine scFv.
CD19 CART
Patients will get one course of CART treatment with the dose of 0.5-5\*10\~6/KgBW.
humanized CD19-CART
All enrolled patients in this arm will receive humanized CD19-CART.
CD19 CART
Patients will get one course of CART treatment with the dose of 0.5-5\*10\~6/KgBW.
Interventions
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CD19 CART
Patients will get one course of CART treatment with the dose of 0.5-5\*10\~6/KgBW.
Eligibility Criteria
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Inclusion Criteria
2. ALL patients not eligible for allogeneic SCT or relapse after allogeneic SCT.
3. Expected survival \>12W.
4. Creatinine \< 2.5 mg/dl.
5. Alanine transaminase (ALT)/Aspartate Aminotransferase (AST) \< 3x normal
6. Bilirubin \<2.0 mg/dl
7. Voluntary informed consent is given.
Exclusion Criteria
2. Uncontrolled active infection.
3. Active hepatitis B or hepatitis C infection.
4. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
5. Previously treatment with any gene therapy products.
6. Any uncontrolled active medical disorder that would preclude participation as outlined.
7. HIV infection.
6 Years
70 Years
ALL
No
Sponsors
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Second Xiangya Hospital of Central South University
OTHER
Bioray Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Yunxiao Xu, MD
Role: PRINCIPAL_INVESTIGATOR
Second Xiangya Hospital of Central South University
Locations
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Shanghai Bioray Inc.
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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SHBYCL001
Identifier Type: -
Identifier Source: org_study_id
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